Active — Not RecruitingNot Applicable

Spanish Study for Molecular Characterization of Thyroid Carcinoma

Spain150 participantsStarted 2021-06-14

Plain-language summary

This project is a retrospective observational study based on the molecular characterization of a Spanish population of patients with refractory radio-iodine differentiated thyroid cancer (DTC) and medullary thyroid carcinoma (MTC) with advanced and / or metastatic disease undergoing systemic treatment, or under clinical observation. Three diagnostic techniques will be performed on formalin-fixed paraffin embedded (FFPE) tumor samples from the study population: immunohistochemistry (IHC), fluorescence by in situ hybridization (FISH) as well as Next-Generation Sequencing (NGS) techniques by means of DNA and RNA analysis (Ion Platform Torrent - Oncomine Focus Assay, 52 gene detection). The results of each patient will be compared in order to correlate the results of each method.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. All participants must be over 18 years old
✓. Obtaining the informed consent signed by the patient or his legal representative.
✓. Have a paraffinized tumor sample available for analysis in the central laboratory, preferably from total thyroidectomy.
✓. Life expectancy greater than 6 months.
✓. Thyroid carcinoma with a date of initial histological diagnosis before January 1, 2021 of the types:
✓. Patients with advanced / metastatic disease in wait \& see follow-up.
✓. Patients with advanced / metastatic disease currently undergoing treatment or in progression to any type of multikinase inhibitor, such as, for example: sorafenib, lenvatinib, cabozantinib, axitinib, vandetanib, ...
✓. Patients with advanced / metastatic disease under treatment or in progression to treatments that inhibit immune checkpoints (anti programed death (PD-1) or its ligand (PD-L1), anti Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), others) or who are participating in clinical trial regimen. They must be patients who have previously progressed to multikinase inhibitors.

Exclusion criteria

What they're measuring

Progression free survival (PFS)

Timeframe: Throughout the study. Approximately 2 years

Overall survival (OS)

Timeframe: Throughout the study. Approximately 2 years

Objective response rate

Timeframe: Throughout the study. Approximately 2 years

Prevalence of genetic alterations

Timeframe: Throughout the study. Approximately 2 years

Trial details

NCT IDNCT04970134

SponsorGrupo Español de Tratamiento de Tumores de Cabeza y Cuello

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-25

View on ClinicalTrials.gov More Differentiated Thyroid Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. All participants must be over 18 years old
✓. Obtaining the informed consent signed by the patient or his legal representative.
✓. Have a paraffinized tumor sample available for analysis in the central laboratory, preferably from total thyroidectomy.
✓. Life expectancy greater than 6 months.
✓. Thyroid carcinoma with a date of initial histological diagnosis before January 1, 2021 of the types:
✓. Patients with advanced / metastatic disease in wait \& see follow-up.
✓. Patients with advanced / metastatic disease currently undergoing treatment or in progression to any type of multikinase inhibitor, such as, for example: sorafenib, lenvatinib, cabozantinib, axitinib, vandetanib, ...
✓. Patients with advanced / metastatic disease under treatment or in progression to treatments that inhibit immune checkpoints (anti programed death (PD-1) or its ligand (PD-L1), anti Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), others) or who are participating in clinical trial regimen. They must be patients who have previously progressed to multikinase inhibitors.

Exclusion criteria

What they're measuring

Progression free survival (PFS)

Timeframe: Throughout the study. Approximately 2 years

Overall survival (OS)

Timeframe: Throughout the study. Approximately 2 years

Objective response rate

Timeframe: Throughout the study. Approximately 2 years

Prevalence of genetic alterations

Timeframe: Throughout the study. Approximately 2 years